Study on Levosimendan for Improving Survival in Patients with Out-of-Hospital Cardiac Arrest During CPR

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Levosimendan on patients who have experienced a cardiac arrest, which is when the heart suddenly stops beating. The trial aims to find out if giving a single dose of Levosimendan during cardiopulmonary resuscitation (CPR) can improve survival rates 30 days after the event, compared to a placebo. Levosimendan is administered through an intravenous injection, which means it is given directly into a vein.

Participants in the study will receive either Levosimendan or a placebo while undergoing CPR for an out-of-hospital cardiac arrest. The study will monitor various outcomes, such as whether the heart starts beating again on its own, if the patient can be transported to the hospital, and the patient’s condition upon arrival at the hospital. The study will also look at the patient’s recovery and health status over time, including any organ function issues and neurological outcomes, which refer to the brain’s ability to function properly after the event.

The trial will also measure the levels of Levosimendan in the blood of those who receive it, to better understand how the body processes the medication. The study is expected to continue until 2027, with the goal of providing valuable information on the potential benefits of Levosimendan in improving survival and recovery after a cardiac arrest.

1 joining the trial

Upon joining the trial, the patient will be informed about the study’s purpose, which is to investigate if a single dose of levosimendan given during cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest increases 30-day survival compared to a placebo.

The patient will be randomly assigned to receive either the levosimendan or a placebo during the trial.

2 administration of medication

During the trial, the patient will receive a single dose of levosimendan or a placebo through an intravenous injection. This means the medication will be delivered directly into the bloodstream through a vein.

The medication used is called Simdax 2.5 mg/ml, which is a solution for infusion.

3 monitoring and follow-up

After the administration of the medication, the patient’s condition will be closely monitored to assess the effects of the treatment.

The primary goal is to determine survival at day 30 after the cardiac arrest event.

Secondary observations include the return of spontaneous circulation, transport to the hospital, and the patient’s condition upon arrival at the hospital.

4 intensive care unit (ICU) observation

If the patient is admitted to the ICU, further monitoring will occur for up to 72 hours. This includes checking the number and duration of any additional medications needed to support heart function.

The patient’s overall organ function and neurological outcomes will also be evaluated during this period.

5 end of trial participation

The trial participation concludes with the assessment of the patient’s condition at the end of the observation period.

The final evaluation will include the patient’s survival status, any organ dysfunction, and neurological outcomes at discharge.

Who Can Join the Study?

  • The cardiac arrest must have been witnessed, meaning someone saw it happen.
  • CPR (cardiopulmonary resuscitation) must have started within 2 minutes of the cardiac arrest.
  • The first recorded heart rhythm must be VF (ventricular fibrillation), pVT (pulseless ventricular tachycardia), or PEA (pulseless electrical activity) if a pulmonary embolism is suspected by the attending physician.
  • The cardiac arrest must be refractory, meaning it continues even after three rhythm checks.
  • The patient must have intravenous access, which means a needle or tube is placed in a vein to give medications or fluids.
  • The patient must be between 18 and 75 years old.

Who Cannot Join the Study?

  • Patients who have experienced a cardiac arrest outside of a hospital setting cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who are not able to give informed consent due to mental or physical conditions are excluded.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate are not allowed.
  • Individuals who are pregnant or breastfeeding cannot take part in the study.
  • Anyone who is currently participating in another clinical trial is excluded.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Rejwfr Sceejsqhi Stockholm Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.09.2025

Trial locations

Investigated drugs:

Levosimendan is a medication used in this clinical trial to help improve heart function during a cardiac arrest. It works by making the heart muscle contract more strongly and efficiently, which can be crucial during a cardiac arrest when the heart stops beating effectively. In this trial, a single dose of levosimendan is given during cardiopulmonary resuscitation (CPR) to see if it can help increase the chances of survival for patients who have experienced an out-of-hospital cardiac arrest.

Investigated diseases:

Cardiac arrest – Cardiac arrest is a sudden loss of heart function, leading to a stop in effective blood circulation. It occurs when the heart’s electrical system malfunctions, causing an irregular heartbeat or arrhythmia. This disruption prevents the heart from pumping blood to the brain, lungs, and other organs. Without immediate intervention, the lack of blood flow can lead to loss of consciousness and cessation of breathing. The condition can occur unexpectedly and requires prompt medical attention to restore normal heart rhythm. It is distinct from a heart attack, which is caused by a blockage that stops blood flow to the heart.

Trial ID:
2024-517279-20-02
Trial Phase:
Therapeutic exploratory (Phase II)

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